Study on AZD2811 and Durvalumab for Treating Extensive Stage Small-Cell Lung Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04745689
This clinical trial is testing a combination of two drugs, AZD2811 and Durvalumab, as a maintenance treatment for patients with extensive stage small-cell lung cancer (ES-SCLC) who have already received initial chemotherapy and Durvalumab.
Patient Parameters
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Program Overview
The study aims to find out if the combination of AZD2811 and Durvalumab can effectively maintain cancer control in patients with extensive stage small-cell lung cancer (ES-SCLC) who have not shown disease progression after initial treatment with platinum-based chemotherapy and Durvalumab. Participants will continue with the AZD2811 and Durvalumab treatment until their cancer progresses, they start a different cancer treatment, experience unacceptable side effects, or choose to leave the study. The study will monitor patients' safety, disease progression, and survival.
Description
This study is designed to evaluate how well the combination of AZD2811 and Durvalumab works as a maintenance therapy for patients with extensive stage small-cell lung cancer (ES-SCLC) who have responded well to initial treatment. Initially, patients will receive platinum-based chemotherapy along with Durvalumab. If their cancer does not progress, they will move on to the maintenance phase, where they will receive AZD2811 and Durvalumab. The treatment will continue until the cancer progresses, the patient starts a new treatment, experiences severe side effects, or decides to stop participating. Throughout the study, patients will be regularly monitored for safety and any changes in their cancer. The study is open to adults aged 18 and older with extensive stage small-cell lung cancer, who are in good overall health and have not previously received immune-based therapies.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of extensive stage small-cell lung cancer (ES-SCLC).
- Be suitable for initial treatment with platinum-based chemotherapy and Durvalumab.
- Have not received any previous immune-based therapy.
- Have a life expectancy of at least 12 weeks from the start of the study.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have had any chest radiation therapy before starting systemic treatment or plan to have chest radiation therapy.
- Have a paraneoplastic syndrome (PNS) that requires treatment with steroids or other immune-suppressing drugs.
- Have an active infection, such as tuberculosis, HIV, or hepatitis B or C.
- Have any active or previously diagnosed autoimmune or inflammatory disorders.
- Have any uncontrolled illnesses, including lung diseases like interstitial lung disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 49503 | Grand Rapids | Michigan |
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